311 related articles for article (PubMed ID: 22025597)
1. Extrapolation of adult data and other data in pediatric drug-development programs.
Dunne J; Rodriguez WJ; Murphy MD; Beasley BN; Burckart GJ; Filie JD; Lewis LL; Sachs HC; Sheridan PH; Starke P; Yao LP
Pediatrics; 2011 Nov; 128(5):e1242-9. PubMed ID: 22025597
[TBL] [Abstract][Full Text] [Related]
2. Improving pediatric dosing through pediatric initiatives: what we have learned.
Rodriguez W; Selen A; Avant D; Chaurasia C; Crescenzi T; Gieser G; Di Giacinto J; Huang SM; Lee P; Mathis L; Murphy D; Murphy S; Roberts R; Sachs HC; Suarez S; Tandon V; Uppoor RS
Pediatrics; 2008 Mar; 121(3):530-9. PubMed ID: 18310202
[TBL] [Abstract][Full Text] [Related]
3. Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.
Momper JD; Mulugeta Y; Green DJ; Karesh A; Krudys KM; Sachs HC; Yao LP; Burckart GJ
JAMA Pediatr; 2013 Oct; 167(10):926-32. PubMed ID: 23921678
[TBL] [Abstract][Full Text] [Related]
4. Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015-2020.
Samuels S; Park K; Bhatt-Mehta V; Sun H; Mulugeta Y; Yao L; Green DJ; Burckart GJ
J Clin Pharmacol; 2023 Mar; 63(3):307-313. PubMed ID: 36150423
[TBL] [Abstract][Full Text] [Related]
5. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.
Roberts R; Rodriguez W; Murphy D; Crescenzi T
JAMA; 2003 Aug; 290(7):905-11. PubMed ID: 12928467
[TBL] [Abstract][Full Text] [Related]
6. Stimulation programs for pediatric drug research--do children really benefit?
Boots I; Sukhai RN; Klein RH; Holl RA; Wit JM; Cohen AF; Burggraaf J
Eur J Pediatr; 2007 Aug; 166(8):849-55. PubMed ID: 17225950
[TBL] [Abstract][Full Text] [Related]
7. Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.
Mulugeta Y; Barrett JS; Nelson R; Eshete AT; Mushtaq A; Yao L; Glasgow N; Mulberg AE; Gonzalez D; Green D; Florian J; Krudys K; Seo S; Kim I; Chilukuri D; Burckart GJ
J Clin Pharmacol; 2016 Nov; 56(11):1326-1334. PubMed ID: 27040726
[TBL] [Abstract][Full Text] [Related]
8. FDA update.
Katz R
Epilepsy Res; 2006 Jan; 68(1):85-94. PubMed ID: 16377143
[TBL] [Abstract][Full Text] [Related]
9. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.
Wharton GT; Murphy MD; Avant D; Goldsmith JV; Chai G; Rodriguez WJ; Eisenstein EL
Pediatrics; 2014 Aug; 134(2):e512-8. PubMed ID: 25022732
[TBL] [Abstract][Full Text] [Related]
10. Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.
Jadhav PR; Zhang J; Gobburu JV
Pharm Stat; 2009; 8(3):216-24. PubMed ID: 19610013
[TBL] [Abstract][Full Text] [Related]
11. Pediatric exclusivity: evolving legislation and novel complexities within pediatric therapeutic development.
Rivera DR; Hartzema AG
Ann Pharmacother; 2014 Mar; 48(3):369-79. PubMed ID: 24311725
[TBL] [Abstract][Full Text] [Related]
12. Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives.
Hirschfeld S; Ho PT; Smith M; Pazdur R
J Clin Oncol; 2003 Mar; 21(6):1066-73. PubMed ID: 12637472
[TBL] [Abstract][Full Text] [Related]
13. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients--FDA. Final rule.
Fed Regist; 1998 Dec; 63(231):66631-72. PubMed ID: 10338880
[TBL] [Abstract][Full Text] [Related]
14. [Are children getting the right drugs?].
Bratlid D
Tidsskr Nor Laegeforen; 2005 Dec; 125(23):3290-2. PubMed ID: 16327857
[TBL] [Abstract][Full Text] [Related]
15. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
16. Role of modeling and simulation in pediatric investigation plans.
Manolis E; Osman TE; Herold R; Koenig F; Tomasi P; Vamvakas S; Saint Raymond A
Paediatr Anaesth; 2011 Mar; 21(3):214-21. PubMed ID: 21244569
[TBL] [Abstract][Full Text] [Related]
17. American Academy of Pediatrics. Committee on drugs. Drug testing in children: FDA regulations.
Pediatrics; 1969 Mar; 43(3):463-5. PubMed ID: 5818481
[No Abstract] [Full Text] [Related]
18. Pediatric dose selection.
Abernethy DR; Burckart GJ
Clin Pharmacol Ther; 2010 Mar; 87(3):270-1. PubMed ID: 20160747
[TBL] [Abstract][Full Text] [Related]
19. New pediatric dosage rules: information and testing.
Feeg VD
Pediatr Nurs; 1998; 24(6):518, 613. PubMed ID: 10085992
[No Abstract] [Full Text] [Related]
20. Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned.
Sun H; Temeck JW; Chambers W; Perkins G; Bonnel R; Murphy D
Ther Innov Regul Sci; 2017; 2017():1-7. PubMed ID: 28890858
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]